Controversial move by FDA sends Claritin over the counter

Despite protests from the drug's manufacturer

Posted: Thursday, November 28, 2002

By Lauran NeergaardAssociated Press

WASHINGTON -- The government approved over-the-counter sales of the popular allergy remedy Claritin on Wednesday, a long-anticipated move that will save uninsured allergy sufferers money but prove more costly to those with prescription drug insurance plans.

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The decision comes four years after a prominent insurance company petitioned the Food and Drug Administration to force Claritin's maker to sell it without a prescription here just like it long has in Canada.

Money aside, proponents of the switch argued that nondrowsy Claritin is safer than today's over-the-counter antihistamines that make people sleepy, very dangerous if they're driving.

Manufacturer Schering-Plough Corp. vehemently fought the switch at first, saying the insurance industry pushed the change because it doesn't pay for over-the-counter medicines -- meaning insurers will save billions in drug costs as well as doctor fees.

But Claritin's patent expires in December, opening the drug to generic competition -- so earlier this year, Schering grudgingly changed course and asked the FDA to allow Claritin to sell without a prescription after all.

Claritin will move next to the aspirin and cough syrup on drugstore shelves in mid-December, but Schering refused to say Wednesday what it will charge for the pills.

To buy Claritin with a prescription before today cost about $60 for a month's supply, plus the doctor's visit. In Canada, a month's supply of nonprescription Claritin is about $17.

Over-the-counter drugs are always at least somewhat cheaper than their prescription-only versions. For people without insurance that covers medications, that's a boon. But allergy sufferers used to a $10 or so insurance co-payment for their drugs would start paying more -- and the question is how much more.

Add to the mix that when generic versions of Claritin debut next year, they, too, will sell without a prescription -- and generic drugs usually are significantly cheaper than their brand-name counterparts.

But allergists say some insurance companies are moving to block access to other prescription antihistamines -- Schering's prescription-only successor to Claritin called Clarinex and the competitors Allegra and Zyrtec -- now that Claritin is nonprescription.

Yet there are some patients who respond only to one drug who will be seriously hurt if insurance coverage ends, said Dr. William Berger, president of the American College of Allergy, Asthma and Immunology.

''The decisions are being made in the boardroom and not in the exam room as to what's in the patient's best interest,'' said Berger, warning that such a move could extend far beyond allergy medications.

''Claritin OTC per se is not the issue,'' Berger added. ''We could be having the same conversation in six months when they decide not to cover ... (the arthritis therapies) Vioxx or Celebrex and say just go buy some Advil.''

Last year, FDA's scientific advisers recommended that the agency move Allegra and Zyrtec over the counter along with Claritin. Those drugs' manufacturers haven't sought the change, but Blue Cross of California petitioned the FDA to force it. The FDA still is debating what to do, said Dr. Robert Meyer, the agency's nonprescription drugs chief.

Analysts predict the Claritin switch will mean revenue from Schering's top-selling drug will shrivel, from worldwide sales of $3.1 billion last year to likely under half a billion dollars next year.

Some 40 million Americans have allergies, and half of them are estimated to use over-the-counter remedies.

Claritin's main advantage over the other nonprescription choices is that it's not sedating -- it won't carry that warning against driving or operating heavy machinery that's so common on over-the-counter drugs.

But anyone who takes higher-than-recommended doses of Claritin, or has kidney or liver disease that slows metabolism of the drug, can experience some drowsiness, Meyer cautioned.